Study Status

Description Value
Participants Enrolled 48
Sites Enrolled 158
Study Status Active
Nickname Protocol Nickname
Description Value
Participants Enrolled 48
Sites Enrolled 158
Study Status Active
Protocol Row Id 1-1G9113
Protocol Number AA-AA-000-0000
Protocol Title Protocol Title
Nickname Protocol Nickname
Protocol Type Investigator Sponsored
Phase P3
Num Plan Site 190
Num Site Actl 176
Est Fpfv 2003-01-01
Act Fpfv 2003-01-01
Est Lplv 2021-06-01
Act Lplv 2021-06-01
Est Lpfv 2020-06-01
Act Lpfv 2020-06-01
Status Active
Num Plan Subj 1300
Num Enrolled Subj M 1301
Protocol Indication Protocol Indication
Product Product
Therapeutic Area Therapeutic Area
Protocol Product Number 123
X Rbm Flg Y

Study Overview

0 Red KRIs
1 Amber KRIs

Summary Charts

Group Overview
Flags Over Time

As of 2012-12-31, AA-AA-000-0000 has 48 participants enrolled across 158 countries. 0 Site-KRI combinations have been flagged across 0 countries as shown in the Study Overview Table above.
  • 0 countries have at least one red KRI
  • 3 countries have at least one red or amber KRI
  • 3 countries have neither red nor amber KRIS and are not shown

Results

Adverse Event Rate

Summary Charts

Summary
KRI Metric
KRI Score
KRI Score
KRI Metric
Numerator

Group Enrolled Numerator Denominator Metric Score Flag
US 43 9724 197416 0.05 -1.05

Serious Adverse Event Rate

Summary Charts

Summary
KRI Metric
KRI Score
KRI Score
KRI Metric
Numerator

Group Enrolled Numerator Denominator Metric Score Flag

Non-Important Protocol Deviation Rate

Summary Charts

Summary
KRI Metric
KRI Score
KRI Score
KRI Metric
Numerator

Group Enrolled Numerator Denominator Metric Score Flag

Important Protocol Deviation Rate

Summary Charts

Summary
KRI Metric
KRI Score
KRI Score
KRI Metric
Numerator

Group Enrolled Numerator Denominator Metric Score Flag

Grade 3+ Lab Abnormality Rate

Summary Charts

Summary
KRI Metric
KRI Score
KRI Score
KRI Metric
Numerator

Group Enrolled Numerator Denominator Metric Score Flag

Study Discontinuation Rate

Summary Charts

Summary
KRI Metric
KRI Score
KRI Score
KRI Metric
Numerator

Group Enrolled Numerator Denominator Metric Score Flag

Treatment Discontinuation Rate

Summary Charts

Summary
KRI Metric
KRI Score
KRI Score
KRI Metric
Numerator

Group Enrolled Numerator Denominator Metric Score Flag

Query Rate

Summary Charts

Summary
KRI Metric
KRI Score
KRI Score
KRI Metric
Numerator

Group Enrolled Numerator Denominator Metric Score Flag

Outstanding Query Rate

Summary Charts

Summary
KRI Metric
KRI Score
KRI Score
KRI Metric
Numerator

Group Enrolled Numerator Denominator Metric Score Flag

Outstanding Data Entry Rate

Summary Charts

Summary
KRI Metric
KRI Score
KRI Score
KRI Metric
Numerator

Group Enrolled Numerator Denominator Metric Score Flag

Data Change Rate

Summary Charts

Summary
KRI Metric
KRI Score
KRI Score
KRI Metric
Numerator

Group Enrolled Numerator Denominator Metric Score Flag

Screen Failure Rate

Summary Charts

Summary
KRI Metric
KRI Score
KRI Score
KRI Metric
Numerator

Group Enrolled Numerator Denominator Metric Score Flag

Metric Details

File MetricID GroupLevel Abbreviation Metric Numerator Denominator Model Type Score Threshold nMinDenominator
cou0001.yaml cou0001 Country AE Adverse Event Rate Adverse Events Days on Study Normal Approximation rate Adjusted Z-Score -2,-1,2,3 30
cou0002.yaml cou0002 Country SAE Serious Adverse Event Rate Serious Adverse Events Days on Study Normal Approximation rate Adjusted Z-Score -2,-1,2,3 30
cou0003.yaml cou0003 Country PD Non-Important Protocol Deviation Rate Non-Important Protocol Deviations Days on Study Normal Approximation rate Adjusted Z-Score -3,-2,2,3 30
cou0004.yaml cou0004 Country PD Important Protocol Deviation Rate Important Protocol Deviations Days on Study Normal Approximation rate Adjusted Z-Score -3,-2,2,3 30
cou0005.yaml cou0005 Country LB Grade 3+ Lab Abnormality Rate Grade 3+ Abnormal Labs Samples Total Lab Samples Normal Approximation binary Adjusted Z-Score -3,-2,2,3 30
cou0006.yaml cou0006 Country SDSC Study Discontinuation Rate Subjects Discontinued - Study Enrolled Subjects Normal Approximation binary Adjusted Z-Score -3,-2,2,3 3
cou0007.yaml cou0007 Country TDSC Treatment Discontinuation Rate Subjects Discontinued - Treatment Enrolled Subjects Normal Approximation binary Adjusted Z-Score -3,-2,2,3 3
cou0008.yaml cou0008 Country QRY Query Rate Queries Total Data Points Normal Approximation rate Adjusted Z-Score -3,-2,2,3 30
cou0009.yaml cou0009 Country OQRY Outstanding Query Rate Queries Open > 30 Days Total Queries Normal Approximation binary Adjusted Z-Score -3,-2,2,3 30
cou0010.yaml cou0010 Country ODAT Outstanding Data Entry Rate Data Pages Entered > 10 Days Total Data Pages Normal Approximation binary Adjusted Z-Score -3,-2,2,3 30
cou0011.yaml cou0011 Country CDAT Data Change Rate Data Points with 1+ Change Total Data Points Normal Approximation binary Adjusted Z-Score -3,-2,2,3 30
cou0012.yaml cou0012 Country SF Screen Failure Rate Screen Failures Screened Subjects Normal Approximation binary Adjusted Z-Score -3,-2,2,3 3